Kornimate/medical-research-clean huggingface dataset:
effectiveness of a nutritional counseling tool in reducing the amount and frequency of sugar intake

Conditions: Dental Cavity; Caries,Dental

Summary: the purpose of the study is to assess the effectiveness of nutritional counselling on added sugar consumption, frequency of snacking and caries experiences expressed as decayed, missing, and filled teeth score (dmft).

the study involves two visits: the first lasting approximately 30-45 minutes, and the second about 15 minutes that occurs 2 weeks after the first visit. procedures and activities. subjects will be assigned to either the control or intervention group by the toss of a coin. subjects will provide information about their personal health history, including age, gender, and race/ethnicity. subjects will undergo an oral examination to assess dental health through a dmft score, which measures decayed, missing, and filled teeth. additionally, the daily added sugar consumption will be calculated using an app called "sugar intake calculator." for the control group, no further nutritional advice will be given, while participants in the intervention group will receive additional guidance on sugar consumption using a tool called stephan's curve. a log will be given to the subjects to track their daily snacking frequency and what type and amount of snack it entailed. after two weeks, subjects will return for a follow-up to evaluate any changes in dental health, sugar consumption, and snacking habits.

Eligibility criteria:
inclusion criteria: * subjects are 18 years or older * subjects who will comply with study protocol * subjects who can read and speak english * subjects available during the study period exclusion criteria: * subjects under the age of 18 * subjects have less than 20 teeth

Keywords: sugar consumption nutritional counselling
a pivotal investigational device exemption study on laminar left atrial appendage elimination

Conditions: Non-valvular Atrial Fibrillation; Stroke; Systemic Embolism

Summary: the purpose of this study is to compare the safety and effectiveness of laminar left atrial appendage closure (laac) device as compared to the commercially available laac devices in participants with non-valvular atrial fibrillation (nvaf) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).

this prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. participants will be randomized 1:1 to the laminar left atrial appendage closure system or commercially available device (watchman™ left atrial appendage closure device / amulet™ left atrial appendage occluder).

Eligibility criteria:
inclusion criteria: * documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (nvaf) * cha2ds2-vasc score greater than or equal to (\>=) 2 in men and \>= 3 in women * deemed to be clinically indicated for left atrial appendage (laa) closure by the site investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care * recommended for chronic oral anticoagulation therapy (oac) but has an appropriate rationale to seek a non-pharmacologic alternative * eligible for the protocol-specified post-procedural antithrombotic regimen * willing and able to comply with the protocol, and has provided written informed consent (participant or legally authorized representative) per institutional review board (irb) requirements exclusion criteria: * single episode, transient, or reversible atrial fibrillation (af) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures) * prior cardiac surgery or any procedure that involved pericardial access * stage iv kidney disease or renal insufficiency, defined as estimated glomerular filtration rate (egfr) less than (\<) 30 milliliters per minute per (ml/min)/1.73 square meters (m\^2) or participants with end stage renal disease who are dialysis dependent * any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (pci), cardiac ablation, cataract surgery) * left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (ifu) (that is, the anatomy and sizing must be appropriate for a control and the laminar device to be enrolled in the study)
evaluating the efficacy of channa striata in stabilizing enos in patients with septic.

Conditions: Sepsis

Summary: sepsis is an inflammation response produced by the host's immune system, which is agrravated by oxidative stress. one of the adjuvant therapy according to surviving sepsis campaign guideline is albumin, which has anti-inflammatory and anti-oxidant effects. however, human albumin is quite expensive, and other forms with similar potency and less costs are needed, one of which is channa striata extract. therefore, this study is conducted to compare albumin and human albumin, specifically their anti- inflammatory and anti-oxidant properties by assessing the enos marker, neutrophil/lymphocyte ratio (nlr) and platelet/lymphocyte ratio (plr) in patient with sepsis.

in summary, this study showed that channa striata extract has a better outcome in stabilizing enos level in patient with sepsis than human albumin 20%, and it has a potential benefit in stabilizing nlr values. however, further studies with a larger sample and a more advanced phase of sepsis are needed.

Eligibility criteria:
inclusion criteria: * patients sepsis who met the qsofa criteria ≧ 2 \[two of which: unconsciousness (glasgow coma scale ≤14) * respiratory rate \> 22 and systolic blood pressure ≤ 100 mmhg\], * aged ≧ 18 years * admitted to intensive care unit and high care unit at dr. moewardi general hospital exclusion criteria: * patients with severe trauma * blood loss in stage three or higher * stress ulcers * a history of nephrotic syndrome * refusal to participate

Keywords: sepsis enos nlr plr channa striata albumin inflammation anti-oxidant
effect of renal transplantation on obstructive sleep apnea in end stage renal disease patients (sasintx)

Conditions: Obstructive Sleep Apnea; Overhydration; End Stage Renal Disease; Renal Transplantation

Summary: the purpose of this study is to investigate the effect of renal transplantation on fluid overload and its consequence on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease. it aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.

obstructive sleep disordered breathing is more prevalent in end stage kidney disease patients than in the general population, and may participate to the increased cardiovascular mortality observed in this group of patients. despite a significant increase in knowledge about the harmful effects of obstructive sleep apnea, the pathophysiological mechanisms are poorly understood. recent observations suggest a causative relationship between overnight fluid displacement from the legs to the neck soft and the severity of obstructive sleep apnea. this mechanism was demonstrated in otherwise healthy subjects, in heart failure patients, and in patients with venous insufficiency. we thus suspect that this pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea in patients with fluid overload, including chronic renal failure. the purpose of this study is to investigate the effect of renal transplantation on fluid overload and its consequence on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease. it aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea. the severity of obstructive sleep apnea is measured by two attended polysomnographies, a baseline psg performed before and a follow-up psg performed 6 month after renal transplantation. overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. patients who are not already transplanted 6 months after the baseline psg will be re-assessed and will be analyzed as control group.

Eligibility criteria:
inclusion criteria: * moderate to severe obstructive sleep apnea, with an apnea-hypopnea index (ahi) ≥ 15/h * age ≥ 18 years * patient with end stage renal disease on waiting list for a renal transplantation (cadaveric or live donor). exclusion criteria: * unstable congestive heart failure * active psychiatric disease * amputation of the lower limbs, proximal to the ankle

Keywords: polysomnography bioimpedance leg fluid shift neck circumference sleep apnea syndromes sleep apnea, obstructive sleep disorders, intrinsic sleep disorders apnea kidney diseases kidney failure, chronic renal insufficiency, chronic renal insufficiency dyssomnias
the comparison of miniinvasive and open pancreaticoduodenectomy for cancer pancreaticobiliary zone

Conditions: Pancreatic Cancer; Bile Duct Cancer; Ampulla of Vater Cancer

Summary: the comparison of miniinvasive and open pancreaticoduodenectomy for cancer pancreaticobiliary zone

minimally invasive surgery is undoubtedly the method of choice for multiple gastrointestinal surgical procedures because of its minimally invasive nature and number of benefits such as reducing postoperative pain, shorter hospital stays, and earlier return to work. current advances in technological innovation and surgical strategies have made surgical procedures on the pancreas a routine practice. however, the use of new surgical techniques in pancreatic surgery has been slow due to the complexity of the operations and the steep learning curve required for their use. for example, minimally invasive pancreatoduodenectomies (mipd) have not yet become widespread. due to these interventions have a complex reconstructive stage mipd are still performed in a very few centers by specialized surgeons. although laparoscopic pd was first described in 1994 and the robotic approach in 2003, mipd still account for less than 14% of all dpe cases. the multicenter randomized controlled trial (leopard-2) for the first time compared laparoscopic and open pancreatoduodenectomy for pancreatic or periampullary tumors. the study that involved 99 patients did not reveal the superiority of laparoscopic pd (lpd) and provided an estimated mortality of 6%; 5 patients died in the laparoscopy group and 1 patient died in the group open pd. the trial was stopped early due to high mortality in the migratory invasive interventions group. therefore, advantages of minimally invasive procedures for removal of pancreato-biliary zone tumors remain controversial. in our study, we analyzed perioperative surgical outcomes and short-term survival outcomes in patients undergoing mipd, including lpd and robotic pd (rpd), as well as "open" proximal pancreatoduodenectomy (opd).

Eligibility criteria:
inclusion criteria: * age: 21-75 years * clinically/histologically established diagnosis of the cancer; * preoperative imaging assessment is resectable or borderline resectable exclusion criteria: * benign tumors of the head of pancreas; * distant metastasis; * conversion to laparotomy; * instrumental findings of the tumor process prevalence; * general somatic status on the asa iii-v scale; * acute pancreatitis; * hyperbilirubinemia above 60 μmol/l (3.51 mg/dl) ((normal range, 4-20 μmol/l)). * patients with intraoperative positive express-histological presence of tumor growth along the border of the pancreas resection

Keywords: pancreatoduodenectomy miniinvasive complication morbidity mortality
ending tobacco use through interactive tailored messaging for cambodian people living with hiv/aids

Conditions: Smoking Cessation; HIV

Summary: the goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with hiv quit smoking.


Eligibility criteria:
inclusion criteria: * 1) being aged ≥18 years * 2) being hiv-positive * 3) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes/day) * 4) willing to set a date for a quit attempt within 2 weeks of study enrollment * 5) being able to provide written informed consent to participate * 6) being able to read khmer (score ≥4 points on the rapid estimate of adult literacy in medicine-short form exclusion criteria: * 1) history of a medical condition that precludes use of nicotine replacement therapy * 2) physician/clinician deemed ineligible to participate based on medical or psychiatric condition * 3) enrolled in another cessation program or use of other cessation medications.
csf cholinergic biomarkers and postoperative cognitive change

Conditions: Necrosis of Femoral Head; Knee Osteoarthritis; Fracture of Lower Limb

Summary: previous study demonstrated that the condition of central cholinergic nerve is important for the postoperative cognitive dysfunction. in present study investigators hypothesized that the acetylcholine concentration in the cerebral spinal fluid is associated to the postoperative cognitive changes in aged patients undergoing osteopathic surgery.


Eligibility criteria:
inclusion criteria: * elder than 60 years old * spoke proficient mandarin chinese * agree to undergoing spinal plus general anesthesia * selected total knee replacement surgery exclusion criteria: * patients with neurological and/or psychiatric diseases, including ad, stroke and psychosis * have contraindication for spinal anesthesia such as clotting disorder local infection in the puncture site * existing cognitive impairment as evidenced by mini-mental state examination scores below 24 * several audition or vision disorder * unwillingness to comply with the protocol or procedures.

Keywords: postoperative cognitive changes acetylcholine in csf surgery
retinal atrophy and neurofilament light chain in people with multiple sclerosis taking ofatumumab

Conditions: Multiple Sclerosis; Tomography, Optical Coherence; Retinal Degeneration; Visual Acuity

Summary: this study aims to assess whether, and the degree to which, ofatumumab modulates or reduces rates of retinal atrophy in people with relapsing-remitting ms (rms), according to baseline serum neurofilament light chain (snfl) levels.

seventy-five people with rms who due to commence or already receiving ofatumumab therapy within 60 days of baseline will be recruited. all recruited participants will be tracked prospectively over a two-year period. participants will complete an optical coherence tomography (oct) scan, visual acuity (va) assessments, edss, and snfl blood level at baseline and every 6 months. participants will be tracked prospectively for 2 years. oct scans, snfl levels, disability score determinations, 100% high-contrast, 2.5% and 1.25% low-contrast letter acuities will be performed every 6 months. results from an existing cohort of approximately 75 healthy controls (hc) from a separate study undergoing annual oct and visual function assessments will be used for comparison purposes.

Eligibility criteria:
inclusion criteria: 1. between 18 - 70 years of age 2. have rms as confirmed by the treating neurologist based on the 2017 revised mcdonald criteria and either * be due to commence ofatumumab within 60 days of baseline oct/va/phlebotomy or * be existing patients attending the center and already receiving ofatumumab, be eligible for inclusion, and already undergoing all of the proposed study procedures. 3. willing to sign informed consent 4. willing to undergo phlebotomy exclusion criteria: * uncontrolled diabetes * uncontrolled hypertension * glaucoma * refractive errors of +/- 6 diopters * other neurologic or ophthalmologic disorders
decamp-1: diagnosis and surveillance of indeterminate pulmonary nodules

Conditions: Lung Cancer

Summary: the goal is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally detected in high-risk smokers.

the detection of early lung cancer among military personnel (decamp) consortium is a multidisciplinary and translational research program that includes 7 veterans administration hospitals (vah), the 4 designated military treatment facilities (mtf) and 4 academic hospitals as clinical study sites, several molecular biomarker laboratories, along with biostatics, bioinformatics, pathology and biorepository cores. the decamp coordinating center will facilitate rapid selection, design and execution of clinical studies within this multi-institutional consortium. the goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest ct who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. the diagnostic performance of four previously established lung cancer biomarkers in this cohort will be validated; 1) a gene-expression biomarker measured in bronchial airway brushings; 2) a proteomic signatures measured in bronchial airway biopsies; 3) a proteomic signature measured in serum; and 4) a signature of serum cytokines. the added value of the molecular markers to clinical and imaging markers routinely used in the diagnostic work up of these patients and develop an integrated model (i.e. clinical, imaging \& molecular markers) that results in the most robust diagnostic predictor will be evaluated.

Eligibility criteria:
inclusion criteria: * 45 years of age or older; * initial diagnosis of indeterminate pulmonary nodule (0.7-3.0 cm); * smoking status: current or former smoker with ≥ 20 pack years (pack years = number of packs per day x number of years smoked) * willing to undergo fiberoptic bronchoscopy; * able to tolerate all biospecimen collection as required by protocol; * able to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for a minimum of two years; * able to fill out patient lung history questionnaire; * willing and able to provide a written informed consent. exclusion criteria: * history or previous diagnosis of lung cancer; * diagnosis of pure ground glass opacities on chest ct; * contraindications to nasal brushing or fiberoptic bronchoscopy including ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease, unstable cardiac or pulmonary disease; inability to protect airway or altered level of consciousness; * allergies to any local anesthetic that may be used to obtain biosamples in the study.
pet imaging to determine the role of pet in the assessment of regional disease in breast cancer (pet predict trial)

Conditions: Breast Cancer

Summary: the overall goal of this study is to determine how fdg-pet can be incorporated into the assessment of the axilla in the staging and treatment of women with early stage breast cancer. a multicentre, prospective, diagnostic accuracy study will be conducted evaluating the ability of positronic emission tomography using fluorodeoxyglucose (fdg-pet) to detect the presence or absence of axillary lymph node metastases in newly diagnosed breast cancer patients with no clinical evidence of spread of disease beyond the breast.

patients will have histologic confirmation of invasive breast cancer and will have a fdg-pet scan prior to axillary node assessment. all patients will have a sentinel node biopsy if any sentinel nodes can be located. patients with a positive sentinel node will have an axillary node dissection. the results of the pet will be compared to the reference standard of histologic examination of all excised (sentinel and non-sentinel) axillary lymph nodes which will be referred to as axillary node assessment. sensitivity, specificity, positive and negative predictive values for pet-fdg will be determined.

Eligibility criteria:
inclusion criteria: * histologic diagnosis of invasive breast cancer, * resectable primary cancer. exclusion criteria: * the diagnosis of invasive breast cancer was made more than 3 months prior to registration, * patient and/or surgeon are not willing to proceed with a snb or and after the pet scan is completed, * patient and/or surgeon are not willing to proceed with a level i and ii and if the snb is positive, if the pet scan shows increased uptake in the ipsilateral axilla, or if the surgeon is still gaining experience in the performance of snb, * snb or and has already been done, * chemotherapy has been given or will be given prior to pet scan or snb or and, * significant serious concurrent medical problems (e.g., uncontrolled diabetes), * patient is pregnant or lactating, * patient is unable to lie supine and with both arms above their heads for pet scan, * known hypersensitivity to fdg, * clinical evidence of regional nodal metastases (fixed, matted axillary nodes), * clinical evidence of distant metastases.

Keywords: breast cancer diagnosis pet positronic emission tomography fluorodeoxyglucose
study of phasix™ mesh for vhwg grade 3 midline hernia repair

Conditions: Hernia; Hernia, Abdominal; Hernia, Incisional

Summary: the purpose of this study is to collect additional data on safety and performance of phasix™ mesh in subjects requiring ventral hernia working group (vhwg) grade 3 midline hernia repair.

approximately 85 subjects, at approximately 12 sites across europe will be enrolled and treated to study the use of phasix™ mesh. all treated subjects will be followed for 2 years post-implantation.

Eligibility criteria:
inclusion criteria: * subject must be diagnosed with incisional midline hernia. * subject has a vhwg grade 3 hernia (as defined in the protocol). * size of hernia ≥ 10 cm2. * subject must be willing to undergo a planned retro-rectus hernia repair (onlay allowed as an exception when retro-rectus placement cannot be achieved; using absorbable suture) with or without component separation technique. exclusion criteria: * subject with \> 4 previous repairs of the hernia under observation. * body mass index (bmi) \> 35 kg/m2. * the subject is on, or suspected to be placed on, chemotherapy medications during any part of the study. * the subject has peritonitis. * known human immunodeficiency virus (hiv) infection (if documented in the subject's record). * the subject has cirrhosis of the liver and/or ascites. * subject is american society of anesthesiology class 4 or 5. * complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible. * the hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides). * subject has intact permanent mesh adjacent to the current hernia to be repaired. * subject's hernia repair requires intraabdominal mesh placement. * surgical technique requires surgical bridge repair as the sole repair. * subject has any condition that, in the opinion of the investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements. * subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding. * subject has an alcohol/substance abuse problem or has had a relapse within 12 months of the screening visit. * subject was involved in another interventional clinical study in the last 30 days prior to informed consent form (icf) signature. * subject is part of the site personnel directly involved with this study. * subject has a life expectancy of less than 2 years at the time of enrollment. * subject has a known sensitivity to phasix™ mesh or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).